Reviewers oppose testosterone patch for female sexual dysfunction

NEW YORK (Reuters Health) - Based on a high rate of adverse effects, little proven efficacy, and unknown long-term safety, authors of a review in the March issue of Drug and Therapeutics Bulletin "cannot recommend" use of a transdermal testosterone patch (Intrinsa, Proctor & Gamble) for use in women with sexual dysfunction.

Intrinsa was recently licensed in the UK for the treatment of women who have hypoactive sexual desire disorder (HSDD) following surgically induced menopause who are receiving concomitant estrogen replacement therapy. However, the authors note that evidence linking low testosterone levels to sexual dysfunction in women is inconclusive.

The report indicates that clinical trials of Intrinsa involved highly selective groups with no comorbidities, and that HSDD was diagnosed either with short, nonvalidated questionnaires or by self-reports.

The small improvements in the active treatment arms were of questionable clinical significance, and there were large placebo responses, the authors explain. The longest trials of Intrinsa were 24 weeks long, leaving questions of long-term safety unanswered.

The US Food and Drug Administration has raised specific concerns about the potential risks of cardiovascular disease and breast cancer, as well as endometrial cancer if the product is used off-label for women who still have their uterus.

According to the summary of product characteristics, between 1% and 10% of users experience acne, hirsutism, alopecia, breast pain, weight gain, insomnia, voice deepening, and migraine. Furthermore, many of the androgenic side effects are not always reversible.

"Many factors are involved in the development of sexual dysfunction," the reviewers note. "Consequently, examination of the personal, relationship, partner function, medical and contextual issues may shed more light on the difficulties rather than purely the pursuit of hormonal status."

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